ZAVEDOS 10 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

IDARUBICIN HYDROCHLORIDE

可用日期:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC代码:

L01DB06

药物剂型:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

IDARUBICIN HYDROCHLORIDE 10 MG/VIAL

给药途径:

I.V

处方类型:

Required

厂商:

PFIZER INC, USA

治疗组:

IDARUBICIN

治疗领域:

IDARUBICIN

疗效迹象:

Antimitotic and cytotoxic agent. Acute non-limphocytic Leukemia (ANLL) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients.Acute limphocytic leukemia (ALL) as second line treatment in adults and children.

授权日期:

2023-02-28

资料单张

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
14/12/2014
םש
רישכת
תילגנאב
רפסמו
םושירה
ZAVEDOS 10MG 059-92-27176-00
םש
לעב
םושירה :
רזייפ
הקיטבצמרפ
מ"עב
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
POSOLOGY AND
METHOD OF
ADMINISTRATION
Idarubicin, as the reconstituted
solution, must be administered only
by the intravenous (IV) route (See
section 6.5). A slow administration
over 5 to 10 minutes via the tubing of
a freely running intravenous infusion
of 0.9% sodium chloride or 5%
dextrose, must be followed. A direct
push injection is not recommended
due to the risk of extravasation,
which may occur even in the
presence of adequate blood return
upon needle aspiration (See section
4.4).
•
ANLL/AML. In adult
ANLL/AML, the recommended
intravenous dose schedule is 12 mg/
m2 daily for 3 days in combination
with cytarabine. Idarubicin may also
be administered as a single agent and
in combination, at a dose of 8 mg/m2
daily for 5 days.
•
ALL. In adult ALL, the
recommended single-agent
intravenous dose is 12 mg/m2 daily
for 3 days. In children with ALL, the
recommended single-agent
intravenous dose is 10 mg/m2 daily
for 3 days.
….
For intravenous use only.
Not for intrathecal use.
Dosage is calculated on the basis of body
surface area.
Acute non- lymphocyticlymphoblastic
leukaemia (ANLL)
Adults
- 12 mg/m2/day i.v. daily for 3 days in
combination with cytarabine.
or
- 8 mg/m2/day i.v. daily for 5 days
with/without combination.
Acute lymphocytic lymphoblastic leukaemia
(ALL)
Adults
As single agent in ALL the suggested dose in
adults is 12 mg/m2 i.v. daily for 3 days.
Children
10 mg/m2 i.v. daily for 3 days, as a single
agent.
All of these dosage schedules should,
however, take into account the
haematologica

产品特点

Zavedos 10 mg LPD CC 22 May 2023
Page 1 of 10
- 2023-0084117
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zavedos
®
10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains10mg idarubicin hydrochloride.
The reconstituted solution contains 1mg/ml.
Excipients with known effect:
Each vial contains 100mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
Sterile, pyrogen-free, orange-red, freeze-dried powder in vial
containing 10mg of idarubicin
hydrochloride, with 100mg of lactose anhydrous.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Antimitotic and cytotoxic agent. Acute non-lymphocytic leukemia (ANLL)
in adults for
remission induction in untreated patients or for remission induction
in relapsed or
refractory patients. Acute lymphocytic leukemia (ALL) as second- line
treatment in
adults and children.
4.2
Posology and method of administration
For intravenous use only.
Not for intrathecal use.
Dosage is calculated on the basis of body surface area.
Acute non- lymphocytic
leukaemia (ANLL)
_ _
_ _
_Adults_
- 12 mg/m
2
/day i.v. daily for 3 days in combination with cytarabine.
or
- 8 mg/m
2
/day i.v. daily for 5 days with/without combination.
Acute lymphocytic leukaemia (ALL)
_ _
_ _
_Adults_
As single agent in ALL
_ _
the suggested dose in adults is 12 mg/m
2
i.v. daily for 3 days.
_ _
_ _
_Children_
10 mg/m
2
i.v. daily for 3 days, as a single agent.
All of these dosage schedules should, however, take into account the
haematological
status of the patient and the dosages of other cytotoxic drugs when
used in combination.
Zavedos 10 mg LPD CC 22 May 2023
Page 2 of 10
- 2023-0084117
Administration of a second course should be delayed in patients who
develop severe
mucositis until recovery from this toxicity has occurred and a dose
reduction of 25% is
recommended.
For directions on dilution of the product before administration, see
section 6.6.
4.3
Contraindications
•
known hypersensi